This invention relates to a surgical suture package. The package is self-contained and permits direct dispensing of one or more sutures.
The significance of packaging is most evident in the packaging of surgical sutures. It is essential that the package protect the product and maintain sterility throughout its period of potential use. Sutures may be stored in hospitals for several years, although the usual storage time is much shorter. It is also essential that the package provide rapid and positive means of identification, and release of the undamaged product, ready for use by the surgeon.
There are many sizes of sutures, and many materials of construction such as catgut or polyglycolic acid for absorbables and silk, cotton, nylon, polyethylene, polyethylene terephthalate, polypropylene, stainless steel, insulated stainless steel and other materials for use as non-absorbables. There are several different needle types in common use including pointed straight, pointed curved, three cornered straight, three cornered curved, curved both regular and reverse cutting, and needles with side cutting edges of various types. The variations and combinations of each of the above, to meet the preferences of many surgeons for different operative procedures, means that the suture manufacturer needs to supply different suture package combinations. These suture package combinations can run into the thousands. The importance of positive identification while maintaining an efficient, economical package can thus be readily appreciated.
It is also important to provide convenience to the surgeon and to limit the risk of accidently enclosing foreign items in the patient by limiting the number of extraneous packaging materials associated with use of the product in the operating theater. A count is often kept to ensure that each item is accounted for and removed from the operating field. Considering the ramifications of accidentally enclosing such material in the patient during surgical procedures, it is absolutely essential to minimize this hazard.
Finally, it is essential in a package containing a surgical needle or needles, that the suture is protected from contact with the sharp point or cutting edge of the needle, which could patially cut the suture or the package. Also, the armed needle edges and point need to be protected to maintain their sharpness.
The prior art generally discloses a surgical suture or sutures packaged in a strippable outer envelope. Contained in the strippable outer envelope is an inner envelope or pouch which is sterile. The suture strand or strands have been formed into various configurations of coils and loops, and are contained in or on various retainers, cards, or reels within the inner envelope.
The suture is normally prepared for the surgeon by stripping the outer envelope and transferring the inner envelope by sterile forceps, or by projecting it across a sterile barrier, into the sterile area of the operating room. The sterile inner envelope is then opened at the time of use.
The package of the present invention has advantages over the prior art. After stripping the outer envelope, the card containing the sutures is exposed. The sutures can then be directly dispensed without opening the card.
Another advantage is that the self-contained suture card can be printed with complete suture and needle identification. Special ink effects, e.g. stripping and coloring used in the printing, allows a color coding description of the suture and/or needle material for ease of identification.
The surgical suture card described above is enclosed in an envelope. At least one web of the envelope is a clear (transparent) material which allows full visibility of the descriptive literature on the card.
The envelope is sealed by methods known in the art, e.g. by heat sealing.
An improved surgical suture package containing multiple surgical suture strands has been invented. The package comprises a panel; a flap adjacent and foldably connected to one side of the panel; a foam layer contained on the coordinating surfaces of the panel and flap; and at least two surgical suture strands contained by the foam layer, with one end of the strands being external to the panel and flap. The improvement comprises a foam receptacle adjacent to the external end of the strands.
In one embodiment, the receptacle contains a plurality of slits, the number of slits essentially equal to or greater than the number of suture strand ends external to the improved package panel and flap. In another embodiment, the external end of each strand is needled.
In still another embodiment, the receptacle is contained on the improved package flap. In yet another embodiment, the receptacle is contained on the improved package panel. In a further embodiment, a score line foldably connects the flap to the panel.
In a still further embodiment, a self-contained package has been invented wherein at least one external edge of the improved package panel and flap contains a locking slit.
An improved direct dispensing surgical suture package containing multiple surgical suture strands has also been invented. The package comprises a first member having a first panel; a first flap adjacent and foldably connected to one side of the first panel; a foam layer contained on the coordinating surfaces of the first panel and flap; and at least two surgical suture strands contained by the foam layer, one end of the strands being external to the first panel and flap.
The package comprises a second member having a second panel; a second flap foldably connected to one side of the second panel, with the first member contained by the second member. The improvement comprises a foam receptacle contained on the second member adjacent to the external end of the strands whereby the end of each strand is contained by the receptacle.
In one embodiment, the receptacle contains a plurality of slits. The number of slits are essentially equal to or greater than the number of suture strand ends external to the first panel and flap. In another embodiment the external end of each strand is needled.
In still another embodiment, the receptacle is contained on the improved second flap. In a further embodiment, a self-contained package has been invented, wherein at least the second flap contains means for locking the second flap to the second panel.
A two part, direct dispensing, sterile surgical suture package has been invented. The first part comprises a panel; a flap adjacent and foldably connected to one side of the panel; a foam layer contained on the coordinating surfaces of the panel and flap; at least two surgical suture strands contained by the foam layer, one end of the strands external to the panel and flap; and a foam receptacle adjacent to the external end of the strands. The second part comprises a strippable envelope. The package first part is contained within the package second part.
A three part direct dispensing, self-contained, sterile surgical suture package has also been invented. The first part comprises a first panel; a first flap adjacent and foldably connected to one side of the first panel; a foam layer contained on the coordinating surfaces of the first panel and flap; and at least two surgical suture strands contained by the foam layer with one end of the strands being external to the first panel and flap.
The second part comprises a second panel; a second flap foldably connected to one side of the second panel; a foam receptacle contained on the second part adjacent to the external end of the strands, with each strand contained by the receptacle; and at least the second flap containing means for locking the second flap to the second panel.
The third part comprises a strippable envelope. The package first part is contained by the second part, and the second part is contained within the package third part.
In one embodiment the second part receptacle contains a plurality of slits. The number of slits is essentially equal to or greater than the number of suture strand ends external to the first panel and flap. In another embodiment, the external end of each strand is needled.